RegDev is looking for senior Safety & Pharmacovigilance Consultant to join our Safety Affairs Services team and lead safety solutions for our clients. We are seeking collaborative & innovative thinkers with deep knowledge & expertise in GVP who are ready to challenge the status quo, not only providing assistance where needed, but someone who is willing to also cultivate and build strong relationships. This is a high customer-facing role; therefore we are seeking individuals with strong customer engagement and professional communication skills.

As a key member of our team, the Senior Consultant – Safety & PV SME, will work side-by-side with our clients and partners, serving as advisors, auditors, trainers, as well as providing professional services as needed. In this role, the candidate will lead the overall delivery of project activities for safety services. They will define and drive business processes, lead the project team in delivering the solution, and guide our partners through the GVP process.

Essential Duties and Responsibilities

• Define strategies, business processes, and implementation program(s) for safety & pharmacovigilance.
• Provide expertise on Safety and Pharmacovigilance for customers and project teams.
• Project management including resource planning, leading and motivating a cross-functional team, and project tracking, budget and time management, and forecasting.
• Managing communication between the project team, client, and other stakeholders.
• Represent Safety Professional Services across multiple engagements and workstreams.
• Interacts on a regular basis with safety colleagues to identify process improvement strategies and provide safety input for all operational aspects of drug safety and pharmacovigilance.
• Develops, maintains and ensures documentation of drug safety and pharmacovigilance processes and procedures.
• As required, participate in strategic planning, workflow development, standard operating procedure updates, development & compliance, audits, data analysis and clinical team meetings.
• Ensure compliance with global regulations and ICH guidelines.

Job Requirements and Education

Education:

• Bachelor’s degree in science (preferred in pharmacy, nursing or life sciences), Master’s degree preferred but not required

Experience:

• Minimum 10 years of pharmaceutical experience with a demonstrated focus in PV operations and compliance in the clinical and post-marketing setting

Other Skills and Abilities: 

• Strong interpersonal, organizational and workload planning skills, along with excellent verbal and written communication skills.
• Excellent attention to detail and accuracy, adaptable to changing priorities.
• Proven ability to manage diverse customers and ensure project delivery to a high degree of satisfaction.
• Ability to quickly understand customer requirements and create corresponding solutions.
• Strong knowledge of Safety and Pharmacovigilance processes and regulations.
• Proven experience defining global business processes for safety.
• Good understanding of global regulations and related business processes
• Ability to thrive in an ambiguous / start-up environment as the business develops and scales.
• Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.

ADA Notations

• Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
• Regular communication (hearing/speaking).
• Approximately 10% travel is required; overnight travel required as needed.
• Lifting up to 25 lbs.
• Routine home and onsite office duties including computer keyboard use.
• Vision requirements include close vision and ability to focus.
• Noise conditions range from quiet to moderate – home office conditions variable.

EQUAL OPPORTUNITY EMPLOYER